Tags

Type your tag names separated by a space and hit enter

Pharmaceutical production of tableting granules in an ultra-small-scale high-shear granulator as a pre-formulation study.
Drug Dev Ind Pharm. 2012 Nov; 38(11):1390-3.DD

Abstract

OBJECTIVE

In some of drug developments, the amount of bulk drug powder to use in early stages is limited and it is not easy to supply a sufficient drug amount for conventional preparation methods. Therefore, an ultra-small-scale high-shear granulator (less than 5 g) (USG) was developed and applied to small-scale granulation as a pre-formulation.

METHOD

The sample powder consisted of 66.5% lactose, 28.5% microcrystalline cellulose and 5.0% hydroxypropylcellulose. The granules were obtained to agitate 5 g of the sample powder with 1.0 mL of water at 300 rpm for 5 min after pre-powder mixing for 3 min by the USG and the manual hand (HM) methods.

RESULTS

The granules were evaluated by the 10% and 90% accumulated particle size and the recoveries of the granules and the powder solid. Median particle size for the USG and the HM methods was 159.2 ± 2.3 and 270.9 ± 14.9 µm, respectively. The USG method had a narrower particle size distribution than those by the HM method. The recovery of the granules by USG was significantly larger than that by the HM method.

CONCLUSION

Characteristics of all of the granules indicated that the USG method could produce higher quality granules within a shorter time than the HM methods.

Authors+Show Affiliations

Graduate School of Industrial Technology, Nihon University, Narashino, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22356186

Citation

Ogawa, Tatsuya, et al. "Pharmaceutical Production of Tableting Granules in an Ultra-small-scale High-shear Granulator as a Pre-formulation Study." Drug Development and Industrial Pharmacy, vol. 38, no. 11, 2012, pp. 1390-3.
Ogawa T, Uchino T, Takahashi D, et al. Pharmaceutical production of tableting granules in an ultra-small-scale high-shear granulator as a pre-formulation study. Drug Dev Ind Pharm. 2012;38(11):1390-3.
Ogawa, T., Uchino, T., Takahashi, D., Izumi, T., & Otsuka, M. (2012). Pharmaceutical production of tableting granules in an ultra-small-scale high-shear granulator as a pre-formulation study. Drug Development and Industrial Pharmacy, 38(11), 1390-3.
Ogawa T, et al. Pharmaceutical Production of Tableting Granules in an Ultra-small-scale High-shear Granulator as a Pre-formulation Study. Drug Dev Ind Pharm. 2012;38(11):1390-3. PubMed PMID: 22356186.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pharmaceutical production of tableting granules in an ultra-small-scale high-shear granulator as a pre-formulation study. AU - Ogawa,Tatsuya, AU - Uchino,Tomohiro, AU - Takahashi,Daisuke, AU - Izumi,Tsuyoshi, AU - Otsuka,Makoto, Y1 - 2012/02/22/ PY - 2012/2/24/entrez PY - 2012/2/24/pubmed PY - 2013/2/12/medline SP - 1390 EP - 3 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 38 IS - 11 N2 - OBJECTIVE: In some of drug developments, the amount of bulk drug powder to use in early stages is limited and it is not easy to supply a sufficient drug amount for conventional preparation methods. Therefore, an ultra-small-scale high-shear granulator (less than 5 g) (USG) was developed and applied to small-scale granulation as a pre-formulation. METHOD: The sample powder consisted of 66.5% lactose, 28.5% microcrystalline cellulose and 5.0% hydroxypropylcellulose. The granules were obtained to agitate 5 g of the sample powder with 1.0 mL of water at 300 rpm for 5 min after pre-powder mixing for 3 min by the USG and the manual hand (HM) methods. RESULTS: The granules were evaluated by the 10% and 90% accumulated particle size and the recoveries of the granules and the powder solid. Median particle size for the USG and the HM methods was 159.2 ± 2.3 and 270.9 ± 14.9 µm, respectively. The USG method had a narrower particle size distribution than those by the HM method. The recovery of the granules by USG was significantly larger than that by the HM method. CONCLUSION: Characteristics of all of the granules indicated that the USG method could produce higher quality granules within a shorter time than the HM methods. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/22356186/Pharmaceutical_production_of_tableting_granules_in_an_ultra_small_scale_high_shear_granulator_as_a_pre_formulation_study_ L2 - https://www.tandfonline.com/doi/full/10.3109/03639045.2011.652637 DB - PRIME DP - Unbound Medicine ER -